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Record W2998576867 · doi:10.1111/bjd.18662

How many people develop anti-drug antibodies to the biologic drug tildrakizumab, and what impact does this have on the effectiveness of their treatment

2020· article· en· W2998576867 on OpenAlexaboutno aff
Alexa B. Kimball, Thomas Kerbusch, Frank van Aarle, Priyanka Kulkarni, Q. Li, Andrew Blauvelt, Kim Papp, Kristian Reich, Diana Montgomery

Bibliographic record

VenueBritish Journal of Dermatology · 2020
Typearticle
Languageen
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsnot available
Fundersnot available
KeywordsMedicineDrugClinical trialAdverse effectAntibodyPharmacokineticsIncidence (geometry)Internal medicinePsoriasisPharmacologyImmunology

Abstract

fetched live from OpenAlex

Biologics are powerful drugs used to treat a range of diseases including psoriasis. They can be very effective; however, the body's immune system, which normally fights off infection, can produce ‘anti‐drug antibodies’ (or ADAs) that see biologics as harmful ‘invaders’ and try to deactivate them. These antibodies may result in serious side effects and/or may reduce the effectiveness of the drug. The authors of this study, based in USA, Canada and Germany, evaluated anti‐drug antibodies in patients participating in three clinical trials of a biologic called tildrakizumab. In the three trials, patients were taking either 100mg or 200mg tildrakizumab. 1400 patients were studied from weeks 12 to 16 of the study, and 780 from weeks 52‐64. Three percent of patients on the 100mg dose developed anti‐drug antibodies. This led to an average reduction in clinical response (meaning the drug did not work so well) at week 52. However, the presence of antibodies was not associated with increased incidence of serious adverse effects (unwanted side effects). Results in patients on the 200mg dose were inconclusive. This drug in the 100mg dose has recently been approved for clinical use in Europe and USA. The authors noted that the incidence of antibodies was less than that observed with other types of biologic drugs. This summary relates to the study: Assessment of the effects of immunogenicity on the pharmacokinetics, efficacy and safety of tildrakizumab

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Bench or experimental · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.416
Threshold uncertainty score0.402

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.017
GPT teacher head0.265
Teacher spread0.248 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designBench or experimental
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations1
Published2020
Admission routes1
Has abstractyes

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